EVIS EXERA III VIDEO SYSTEM

K131780 · Olympus Medical Systems Corp. · FDF · Aug 29, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K131780
• Device Name: EVIS EXERA III VIDEO SYSTEM
• Applicant: Olympus Medical Systems Corp.
• Product Code: FDF · Gastroenterology, Urology
• Decision Date: Aug 29, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Endoscopes (GASTROINTESTINAL VIDEOSCOPE GIF-H190, GIF-HQ190, COLONOVIDEOSCOPE CF-HQ190L/I, CF-H190L/I, PCF-H190L/I, PCF-PH190L/I) This instrument is intended to be used with an Olympus video system center, endoscope position detecting unit (for CF-HQ190L/I), light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-H190, GIF-HQ190 are indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). The EVIS EXERA III COLONOVIDEOSCOPE CF-H190L/I, CF-HQ190L/I, PCF-PH190L/I, PCF-H190L/I are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). CV-190 VIDEO SYSTEM CENTER This video system center is intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation. CLV-190 XENON LIGHT SOURCE This light source is intended to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

Device Story

EVIS EXERA III VIDEO SYSTEM is an endoscopic imaging platform for the digestive tract. System components include CV-190 video system center, CLV-190 xenon light source, and various gastrointestinal/colonovideoscope models. Device captures optical images via endoscope camera heads; processes signals through the video system center; displays real-time video on monitors for clinician observation. Used in clinical settings by physicians for diagnosis and endoscopic surgery. Output assists clinicians in visualizing anatomy, identifying pathology, and guiding EndoTherapy accessories (e.g., biopsy forceps). System facilitates minimally invasive procedures, potentially reducing patient trauma compared to open surgery.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on identical technological characteristics and design to the predicate device. Risk analysis performed per ISO 14971:2007.

Technological Characteristics

Endoscopic video imaging system comprising video system center, xenon light source, and flexible endoscopes. System utilizes optical imaging and electronic signal processing. Designed to meet applicable safety standards. Software is classified as Moderate Level of Concern.

Indications for Use

Indicated for patients requiring endoscopic diagnosis, treatment, or observation of the upper digestive tract (esophagus, stomach, duodenum) or lower digestive tract (anus, rectum, sigmoid colon, colon, ileocecal valve).

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• EVIS EXERA III VIDEO SYSTEM (K112680)

Submission Summary (Full Text)

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## 510(k) Summary

## 1. General Information

- 트 OLYMPUS MEDICAL SYSTEMS CORP. Applicant: 2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, Japan Establishment Registration No .: 8010047
- Official Correspondent: Daphney Germain-Kolawole Regulatory Affairs Project Manager Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610 Phone: [phone] FAX: [phone]
- Prepared Date: June 14, 2013

**AUG** 2 9 2013

#### 2. Device Identification

| ■ | Device Trade Name: | EVIS EXERA III VIDEO SYSTEM |
|---|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Common Name: | ENDOSCOPIC VIDEO IMAGING SYSTEM |
| | Regulation Number: | 876.1500 |
| ■ | Regulation Name: | Endoscope and Accessories |
| ■ | Regulatory Class: | II |
| E | Classification Panel: | Gastroenterology and urology |
| 트 | Product Code: | (colonoscope and accessories, flexible/rigid)<br>FDF<br>(gastroscope and accessories, flexible/rigid)<br>FDS<br>NWB (endoscope, accessories, narrow band spectrum) |

#### 3. Predicate Devices

| <br>• | EVIS EXERA III VIDEO SYSTEM (K112680) |
|-------|---------------------------------------|
|-------|---------------------------------------|

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## 4. Device Description

The EVIS EXERA III VIDEO SYSTEM consists of Olympus camera heads, endoscopes, video system center, light source, monitors, EndoTherapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation within the upper and lower digestive tract.

The primary components of the subject system are:

- VIDEO SYSTEM CENTER OLYMPUS CV-190
- XENON LIGHT SOURCE OLYMPUS CLV-190
- ENDOSCOPES
- · GASTROINTESTINAL VIDEOSCOPE (GIF-H190,GIF-HQ190, GIF-XP190N)
- o COLONOVIDEOSCOPE (CF-HQ190L/I, CF-H190L/I, PCF- PH190L/I, PCF- H190L/I)

#### 5. Indications for Use

#### Endoscopes (GASTROINTESTINAL VIDEOSCOPE GIF-H190, GIF-HQ190, COLONOVIDEOSCOPE CF-HQ190L/L, CF-H190L/I, PCF-H190L/I, PCF-PH190L/I)

This instrument is intended to be used with an Olympus video system center, endoscope position detecting unit (for CF-HQ190L/l), light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.

The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-H190, GIF-HO190 are indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).

The EVIS EXERA III COLONOVIDEOSCOPE CF-H190L/I, CF-HQ190L/I, PCF-PH190L/I.

PCF-H190L/1 are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).

#### CV-190 VIDEO SYSTEM CENTER

This video system center is intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.

#### CLV-190 XENON LIGHT SOURCE

This light source is intended to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

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## 6. Technological Characteristics

The purpose of this notification is to add an additional colonoscopy-related marketing claim to the EVIS EXERA III VIDEO SYSTEM. There are no new technological features incorporated in the EVIS EXERA III VIDEO SYSTEM in this notification. The proposed video system center and xenon light source, and endoscopes have the identical technological features to the predicate devices. respectively. The subject system has been designed to meet the applicable safety standards.

## 7. Summary of Non-clinical Testing

Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The purpose of this notification is to add a colonoscopyrelated marketing claim to the previous cleared under K112680. No design changes have been made to the EVIS EXERA III VIDEO SYSTEM other than this marketing claim modification.

The software validation activities were performed in accordance with the FDA Guidance, * Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a "Moderate Level of Concern."

## 8. Conclusion

When compared to the predicate devices, the EVIS EXERA III VIDEO SYSTEM does not incorporate any significant changes in intended use, methods of operation, materials, or design that could affect the safety or effectiveness

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 29, 2013

OLYMPUS MEDICAL SYSTEMS CORP. % Daphney Germain-Kolawole Regulatory Affairs Project Manager Olympus Corporation of the Americas 3500 Corporate Parkway Center Valley, PA 18034

Re: K131780

Trade/Device Name: EVIS EXERA III VIDEO SYSTEM Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF, FDS, NWB Dated: August 5, 2013 Received: August 6, 2013

Dear Daphney Germain-Kolawole,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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#### Page 2 - Daphney Germain-Kolawole

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fdagov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive. Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K131780

Device Name: EVIS EXERA III VIDEO SYSTEM

Indications For Use:

Endoscopes (GASTROINTESTINAL VIDEOSCOPE GIF-H190, GIF-HQ190,

#### COLONOVIDEOSCOPE CF-HQ190L/I, CF-H190L/I, PCF-H190L/I, PCF-PH190L/I)

This instrument is intended to be used with an Olympus video system center, endoscope position detecting unit (for CF-HQ190L/), light source, document, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.

The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-H190, GIF-HQ190 are indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).

The EVIS EXERA III COLONOVIDEOSCOPE CF-H190L/I, CF-HQ190L/I, PCF-PH190U/I, PCF-H190L/I are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).

#### CV-190 VIDEO SYSTEM CENTER

This video system center is intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.

#### CLV-190 XENON LIGHT SOURCE

This light source is intended to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

Prescription Use ア (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

IPLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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## Benjamin R. Fisher -S 2013.08.29 15:14:30 -04'00'

Section5 Indications for Use Page 2 of 2